KUCHING, April 5: Sarawak General Hospital (SGH) will become a focused site in bringing in more international clinical trials, including early phase studies from AstraZeneca, one of the top global biopharmaceutical companies.
This collaboration was formalised through a Memorandum of Understanding (MOU) between AstraZeneca Sdn Bhd with Clinical Research Malaysia (CRM) and SGH after the CRM Annual Report launch in Putrajaya today.
The signing ceremony at the Ministry of Health (MOH) office in Putrajaya between Cluster Chief Financial Officer Pneh Tee Koon representing AstraZeneca and CRM chief executive officer (CEO) Dr Akhmal Yusof was witnessed by Minister of Health Dr Zaliha Mustafa and AstraZeneca Malaysia company director Dr Sanjeev Panchal.
According to a media release, this MOU builds on SGH’s accreditation in 2019 as a Phase 1 site after successfully undergoing the National Pharmaceutical Regulatory Agency Phase 1 Unit Inspection & Accreditation Programme.
The inking of this MOU spells out opportunities to provide early access for patients with unmet medical needs as well as access to innovative medicines that can transform health outcomes and reduce the national disease burden.
Through this collaboration, both parties agree to cooperate to achieve the common goal of delivering quality studies that meet international standards, support training for investigators and study teams, and create more clinical trial opportunities for SGH.
In her speech, Dr Zaliha said she is proud to note that last year, Malaysia recorded the highest number of sponsored research since CRM’s establishment a decade ago.
“With the investment that we have made in early phase development in the country, the MOU with AstraZeneca further consolidates the MOH effort in progressing the clinical research agenda in Malaysia for the betterment of our patients,” she emphasised.
Commenting on the partnership with CRM, Dr Sanjeev said AstraZeneca is deeply committed to better understanding and serving patients by supporting Malaysia’s advancement as a world-class hub for clinical trials.
“To achieve this, our plan is to invest RM53.5 million by 2025, covering studies on the effectiveness of new therapies and for the establishment of a new Site Management and Monitoring (SMM) base in Malaysia. Since 2020, we have invested RM14 million in clinical trials in Malaysia.
“AstraZeneca’s new SMM base will work closely with CRM and SGH as the primary centre to optimise the clinical trials’ study delivery and quality across 32 investigational sites in the country,” he said.
Dr Sanjeev further stated that SMM will also collaborate with AstraZeneca’s global R&D functions to execute pre-marketing internal delivery clinical studies, as well as work with local healthcare professionals, regulatory authorities, and ethics committees to manage the clinical trials.
In the 2022 Annual Report, CRM revealed that Malaysia has surpassed the RM1 billion mark in gross national income of clinical research contract value generated since 2012.
The country also reported more than 2,000 sponsored research projects approved by the various ethics committees in the last decade, and thus ranks third among Southeast Asia countries in this field.
CRM emphasised that Malaysia has been the destination of choice for many biopharmaceutical and contract research organisations especially with capable and experienced clinical research investigators who have been recognised in delivering clinical trials that meet the recruitment expectations of global multinational organisations, with many of Malaysia’s investigators achieving Global Top Recruiters and First Recruiters in their trials.
At the event, Dr Zaliha also launched the organisation’s Anti-Corruption Plan (OACP 2023–2027) in which CRM has emphasised its commitment in demonstrating integrity and holding on to its highest standards of ethics in its operations through its anti-bribery management system.
Health director-general Tan Sr Dr Noor Hisham Abdullah and deputy director-general of Health Research and Technical Support Datuk Dr Muhammad Radzi Abu Hassan as well as SGH head of Clinical Research Centre Dr Alan Fong and head of Radiotherapy and Oncology Department Dr Voon Pei Jye were also present. — DayakDaily
